Feasibility of Dynamic Muscle Stimulation + Radiofrequency for Improving Blink Quality in Subjects with Dry Eye Disease

Lumenis Be Ltd.30 enrolled

Overview

To demonstrate that DMSt + RF improves eye blink quality in subjects with dry eye disease

The purpose of the study is to demonstrate that a combination of DMSt and RF applied on the periocular skin below the lower eyelids improves eye blink quality in subjects with moderate to severe signs and symptoms of dry eye disease.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eyelid Diseases Eyelid Movement Disorders Dry Eye Dry Eye Syndromes Skin Laxity

Interventions

TriLift deviceDEVICE

Dynamic Muscle Stimulation combined with tripolar Radiofrequency, administered on the skin of the inferior orbital rim and below the lower eyelids

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is able to read, understand and sign an Informed Consent Form (ICF) * 22 or older * Lower lid laxity, as clinically judged with lower lid DT and the snapback test * Moderate to severe OSDI (larger or equal to 23) * TBUT smaller or equal to 5 sec in both eyes Exclusion Criteria: * Abnormally high blink rate, as estimated by the study investigator * Any ocular surgery or eyelid surgery, within 3 months prior to screening * Blepharoptosis * Moderate or Severe Floppy Lid Syndrome * Corneal Dystrophy * Exophthalmos * Thyroid Eye Disease * Ocular Chemical Injury or burn * Limbal Stem Cell Deficiency * Facial Nerve Palsy * Blepharospasm * Hemifacial Spasm * Corneal neuropathy * Pregnant or nursing women * Participation in a different study * Any condition revealed whereby the study investigator deems the subject inappropriate for this study

Locations (1)

Manhattan Face and Eye Cosmetic and Orbital Surgery

New York, New York, United States

Outcomes

Primary Outcomes

Impaired blink quality

binary (yes/no) variable, based on clinical estimation of the study investigator who will use a combination of two complementary tests (the lower lid distraction test and the snap-back test) to reach a yes/no decision.

Time frame: 7 weeks after baseline (4 weeks after the 4th treatment)

Data from ClinicalTrials.gov

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